Nanotechnology Policy, Standards, and Guidance

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Nanotechnology Policy, Standards, and Guidance

• Bill McArthur, PhD, CIH
• Director, Office of Worker Safety and Health
  Policy
• Office of Health and Safety

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Standards and Guidance
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Nanotechnology

• New Nano Products
• 3-4 per week
• Economic Impact (with in next 10 years)
• 1,000,000,000,000 - global economy
• 2,000,000 - workers
• 1,000,000 - U.S. workers

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Nanoparticles

• Engineered Nanoparticle
• Purposely produced with one dimension between 1
  and 100 nanometers
• Unique physical and chemical properties
• Characteristics include
• Size
• Shape
• Surface area
• Charge
• Chemical properties
• Solubility

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Health Effects

• LITTLE is known about the effect of Nanoparticles
  on Human Health
• Precautionary Measures Are Warranted

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Health Effects

• Respiratory system greatest potential for
  exposure
• Ingestion
• Skin Contact
• Nanoparticles can enter the blood stream and
  translocate to other organs (animal studies)
• Lung Fn decrement, obstructive and fibrotic lung
  disease (worker studies)
• Research is Needed

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Exposures

• Low Risk of Exposure
• Composites
• Surface coated
• Integrated circuits
• May be of Concern in some processes
• Cutting
• Grinding
• Maintenance
• Cleaning and disposal of materials

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Exposures

• Increased Risks of Exposures
• Working with Liquids
• Inadequate protection (i.e., gloves)
• Mixing, Pouring, Agitation of materials
• Handling/ Generation in non-enclosed systems
• Weighing
• Blending
• Spraying

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Exposures Measure

• Uncertain what Measures should be used to Monitor
  exposures
• Mass and bulk chemistry lt important than size,
  shape, surface area and chemistry
• Background measurements before production
• Evaluation engineering controls and work practice

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Controls

• Limited Information on Health Risks
• Education and Training
• Establish criteria
• Engineering controls i.e., ventilation
• Selecting PPE
• Evaluate Exposures
• Use engineering controls similar to aerosols
• HEPA should effectively remove nanomaterials
• Good Work Practices
• Respiratory Protection / PPE in general

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Medical Surveillance

• Health Surveillance Essential for Effective
  Occupational Safety and Health Program
• No Clear Approach to Medical Surveillance for
  Nanoworkers
• NIOSH
• insufficient scientific and medical evidence
  now exist to recommend the specific medical
  screening of workers potentially exposed to
  engineered nanoparticles. However, NIOSH did
  recommend that hazard surveillance be conducted
  as the basis for implementing control measures.

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Medical Surveillance

• ISO/TR 128852008(E)
• It is recommended that a basic worker health
  monitoring program is established.72 Such a
  program should include at a minimum
• 1. identifying staff (nanoparticles workers)
  exposed to engineered nanoparticles of unknown
  healtheffects
• 2. conducting workplace characterization and
  worker exposure assessments
• 3. providing nanoparticles workers with
  baseline medical evaluations and including them
  in anonspecific routine health monitoring
  program.
• It is recommended to ensure that engineered
  nanoparticle workers are offered periodic medical
  evaluationsthat might include routine tests such
  as pulmonary, renal, liver, and hematopoietic
  function testing.

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Medical Surveillance

• ASTM E 2535 07
• Medical SurveillanceFor guidance on medical
  surveillance of UNP workers consult the NIOSH
  Nanotechnology homepage.
• 9.4.5.1 Whether a medical surveillance program is
  warranted is a management decision to be made in
  consideration of a number of factors including
  whether there is good reason to believe that
  adverse health effects may occur as a result of
  the contemplated exposure the invasiveness of
  the surveillance procedures, the benefits, risks
  and costs of the surveillance method and the
  utility of the information reasonably expected to
  be generated by the surveillance program.
• 9.4.5.2 Any medical surveillance program should
  be developed and implemented only with medical,
  industrial hygiene and legal professional
  consultation, and under the direction of a
  physician experienced in medical surveillance
  programs with a high level understanding of the
  available information concerning the UNP and
  potential exposure circumstances.

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Nanotechnology Policy at the Department of Energy
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DOE Directives System

• Departmental Expectations for Federal Staff
  Conveyed by Directives
• Types of Directives
• Policy High Level
• Notice 1 year limit
• Order List Requirements
• Guides andTechnical Standards
• Guidance Only
• Apply to Contractors Only if In Contract

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Contract Mechanism

• Department of Energy Accusation Regulations
  (DEAR)
• List A Required
• Rules, State, and Local Requiremnts
• List B Negotiated
• Rules
• Follow Administrative Procedures Act

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Worker Safety and HealthPolicy

• DOE Order 440.1B Worker Protection Management
  for DOE and NNSA Federal Employees
• Applies Only to Federal Employees
• 10 CFR 851 Worker Safety and Health Program
• Applies Only to Contractor Employees
• 10 CFR 850 Chronic Beryllium Disease Prevention
  Program
• Applies to both Federal and Contractor Employees

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Why DOE Needs Nanotech Policy

• DOE has critical interests in this area, and a
  major role in the federal research and
  development initiative
• FY 2007 258M at DOE (nearly 100M in
  construction and operation of scientific user
  facilities, and over 150M in basic research)
• DOE-supported research activities span a broad
  range of nanotechnologies
• DOE user facilities provide state-of the-art
  resources to the science and technology community
  via peer-reviewed allocation of instrument time,
  staff support, and collaboration

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Why DOE Needs Nanotech Policy

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Nanotech Policy

• Safety and Health Bulletin Good Practices for
  Handling Nanomaterials
• DOE P 456.1 Secretarial Policy Statement On
  Nanoscale Safety
• 10 CFR 851 Appendix A 11 Nanotechnology Safety
  Reserved
• DOE N 456.1 The Safe Handling of Unbound
  Engineered Nanoparticles

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Development of Nanotech Policy

• Raise Managements Level of Awareness
• Ensuring the Safety and Viability of
  Nanotechnology
• Analogies of Other Technology i.e., Nuclear Power
  and Biotechnology
• Nanotechnology White Paper
• Review of Potential Public and Health, Safety,
  and Environmental Concerns

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Work with Stakeholders

• Nanotechnology Notice Working Group
• Office of Health, Safety and Security
• Under Secretary for Science
• National Nuclear Safety Administration
• Under Secretary
• National Laboratory Directors Council

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Develop Directive

• Leverage existing stake holders knowledge
• Leverage Existing Standards and Drafts
• NSRC - Approaches Document
• ASTM Terminology for Nanotechnology
• ASTM Guide for Handling Unbound Engineered
  Nanoparticles in Occupational Settings
• NIOSH Approaches to Safety Nanotechnology
• Use existing knowledge of highly hazardous
  operations

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Obtain Concurrences Publish Directive

• Departmental Review
• Review and Comment System Rev-Com
• All Essential Comments Must be Resolved
• Notice published Jan 05, 2009
• Requirements
• Requirements for Federal Laboratories
• Contractor Requirements Document (CRD)
• Must be added to Contracts

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References

• Department of Energy Nanoscale Science Research
  Centers, Approach to Nanomaterial ESH (5-12-08,
  Rev 3a).
• ASTM E2535-2007, Standard Guide for Handling
  Unbound Engineered Nanoscale Particles in
  Occupational Settings.
• ISO/TR 12885 (2008-10-01), Nanotechnologies-
  Health and Safety Practices in Occupational
  Settings Relevant to Nanotechnologies.
• ASTM E2456-06, Terminology for Nanotechnology.
• NIOSH, Approaches to Safety Nanotechnology
  Managing the Health and Safety Concerns
  Associated with Engineered Nanomaterials
  (3/2009).
• 10 CFR 851, Worker Safety and Health Program
• DOE O 440.1B, Worker Protection Program for DOE
  (Including the National Nuclear Security
  Administration) Federal Employees (5-17-07)
• DOE P 456.1, Policy on Nanoscale Materials
  (9-15-05.)
• DOE N 456.1, The Safe Handling of Unbound
  Engineered Nanoparticles (1-5-09)